FORADIL® AEROLIZER® inhalation powder, hard capsules Important note: Before prescribing, consult full prescribing information. Presentation: Each capsule contains 12 micrograms formoterol fumarate dihydrate.
Indications: Prophylaxis and treatment of bronchoconstriction in patients with asthma only
as add-on therapy to an inhaled corticosteroid (ICS). Prophylaxis of exercise, cold air or allergen-induced bronchospasm Prophylaxis and treatment of bronchoconstriction in patients with reversible or irreversible chronic obstructive pulmonary disease (COPD).
Dosage: Adults: Regular maintenance therapy (asthma and COPD): 1 to 2 capsules (12-
24 microgram) twice daily. Provided the maximum daily dose is not over 48 micrograms, if needed, 1 or 2 additional capsules per day but on no more than 2 days per week. Prophylaxis against exercise or allergen-induced bronchospasm: 1 capsule used at least 15 minutes prior to exercise or exposure. In patients with history of severe bronchospasm, 2 capsules may be necessary as prophylaxis. In asthma patients, the medication should also include an ICS to treat the asthma. Children 5 years of age and older: Regular maintenance therapy (asthma):
1 capsule twice daily. Treatment with a combination product containing an ICS and long-
acting beta2-agonist (LABA) is recommended in children 5 to 12, except where a separate ICS and LABA are required. Prophylaxis against exercise or allergen-induced bronchospasm: 1 capsule used at least 15 minutes prior to exercise or exposure. In asthma patients, the medication should also include an ICS to treat the asthma.
Contraindications: Hypersensitivity to formoterol or the excipient (lactose monohydrate which contains milk proteins).
Precautions/Warnings: Increased rate of asthma related death observed with another
LABA (salmeterol). Treatment not to be increased beyond maximum recommended dose.
Not to be used with another LABA. To be used only as additional therapy with an ICS. When treating patients with asthma, must only be used together with anti-inflammatory therapy which should continue unchanged after introduction of Foradil®. Reduce Foradil dose gradually once asthma is controlled. In children (5 to 12) treatment with a combination product containing an ICS and LABA is recommended, except where a separate ICS and LABA are required. Not to be initiated or dose increased during asthma exacerbation. Not to be used for acute asthma attacks. Caution is recommended in patients with ischemic heart disease, cardiac arrhythmias (especially third-degree atrioventricular block), severe cardiac decompensation, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm, phaeochromocytoma, hypertrophic obstructive cardiomyopathy, thyrotoxicosis, known or suspected prolongation of the QT interval, diabetes mellitus. Risk of serious hypokalaemia especially in severe asthma. Discontinue if paradoxical bronchospasms occur. Persistent symptoms require medical reassessment. Avoid use during pregnancy or breast-feeding. For
inhalation only, should not be swallowed. Discuss with the patient how to correctly use Foradil Aerolizer. If a patient does not experience breathing improvement, ask how the patient is using Foradil Aerolizer. Adhere strictly to storage instructions.
Interactions: Caution when used concomitantly with beta-adrenergic blockers (including eye drops), drugs prolonging the QTc interval (e.g. quinidine, disopyramide, procainamide,